Bausch & Lomb Incorporated v Allergan, Inc

[1992] APO 44

official notice

decision of a delegate of the commissioner of patents

Application        :   No. 583482 in the name of BAUSCH & LOMB   INCORPORATED

Title             :   Improved method for enzymatic cleaning   and disinfecting contact lenses

Action : Opposition under s.59 of the Patents Act 1952 by ALLERGAN, INC.

Decision           :   Issued            .  Claims do not   comply with section 40.  Applicant given   the opportunity to amend.

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 583482 by BAUSCH & LOMB INCORPORATED and an Opposition under s.59 of the Patents Act 1952 by ALLERGAN, INC.

background

Bausch & Lomb Incorporated lodged patent application No. 583482 under the Patents Act 1952 on 22 October 1984. This was a Convention application based on an earlier US application lodged in The USA on 24 October 1983.

The Office advertised acceptance of the application on 4 May 1989.  Allergan, Inc. (Allergan) lodged notice of its opposition to the acceptance of the application on 1 August 1989. Subsequently, on 1 May 1991, Allergan indicated that it had completed serving evidence in support.  The applicant chose not to lodge evidence in answer.

The Office set down the matter for hearing on 2 June 1992. Mr. Greg Turner, patent attorney of Spruson & Ferguson, represented the applicant at the hearing.  Mr. John Slattery, patent attorney of Davies Collison Cave, represented the opponent.

The notice of opposition specified the grounds of opposition as those listed in paragraphs (c) to (e) of sub-section 59(1). However during the course of the hearing the opponent indicated that only those grounds in paragraphs (e), (g), (h) and (i) would be relied on viz. prior publication, obviousness, lack of novelty and non-compliance with section 40.

SPECIFICATION

The specification commences by indicating that the invention relates to improved methods for cleaning and disinfecting contact lenses through the use of enzymatic cleaners wherein the time interval needed to complete the process can be significantly reduced.

This is followed by a discussion of the prior art where it is admitted that enzyme cleaning solutions containing mainly proteolytic enzymes have been widely used.

The specification then discusses the problems associated with prior art contact lens cleaning methods.  It is indicated that the cleaning process requires two main steps viz. the cleaning step and a disinfecting step.  These two steps when used to clean soft contact lenses with enzyme cleaners can take up to 13 hours.
The specification indicates that the present invention overcomes this inconvenient length of time by combining the two steps into a single step taking 60 minutes or less.  The method of the invention is indicated as having the added benefit of concurrent deactivation of the active enzymes by the time the cycle is complete.

In the subsequent "Summary of the Invention", the specification states that the invention relates to:

"...methods of treating contact lenses having proteinaceous tear film deposits and debris wherein the lenses are heated in aqueous solutions of a proteolytic enzyme to a temperature sufficient to disinfect the lenses and allow the enzyme to effectively clean in a single step in the same solution.  During the heating phase, the lenses are heated up in the enzyme cleaning solution to temperatures of less than 1000C which are maintained for a time period, e.g. usually less than 15 minutes, and then allowed to cool to room temperature."

Then follows a list of suitable enzymes which can be used in the inventive method.

The specification then describes nine embodiments of the invention which correspond to the nine independent claims.

In the description of the preferred embodiment two paragraphs of particular interest occur on page seven.  They are as follows:

"Lenses are covered with the above aqueous enzyme solutions, usually in a lens case, are heated to a temperature which will disinfect and allow cleaning in one-step in the same solution.  This is preferably carried out by a cycle consisting of a heating phase and a cooling phase.  The heating phase consists of gradually elevating the temperature of the solution from ambient temperature to a maximum temperature of usually less than 1000C, and more specifically, from about 600C to about 850C.  When the maximum temperature has been reached the temperature is maintained usually for not more than 20 minutes, and more often for about 5 to about 15 minutes.

Although the precise mechanism for the cleaning reaction remains uncertain the activity of the enzymes for example, in denaturing and removing protein from lens surfaces is believed to be enhanced as the temperature rises.  Likewise, when the maximum temperature has been reached during the heating phase and maintained for about 10 minutes, this action operates automatically to inactivate the enzyme terminating the cleaning process while simultaneously disinfecting the lenses.  At the conclusion of the heating phase the cooling phase commences whereby the cleaned and disinfected lenses and the inactivated cleaning solution are allowed to cool to ambient temperature.  The lenses are then ready for inserting onto the eyes."

Two examples are provided as part of the preferred embodiment.

The specification ends with 32 claims nine of which are independent claims.

The following claims were referred to at the hearing.

1.A method for

(1) cleaning contact lenses of proteinaceous and other deposits using a proteolytic enzyme in aqueous solution, and

(2) disinfecting the contact lenses, the method comprising placing the lenses in a solution comprising a proteolytic enzyme dissolved in water at about room temperature and then heating the solution and the lenses to an elevated temperature of more than 600C and less than 1000C for a period of time of 60 minutes  or less, sufficient to clean and disinfect the lenses, said cleaning and disinfecting being conducted in the same aqueous solution.

2.The method of Claim 1 wherein the heating step is a plurality of cycles wherein each of said cycles consists of a heating phase followed by a cooling phase.

3.The method of Claim 1 or Claim 2 wherein the cleaning and disinfection of the lenses is completed in 50 minutes or less.

4.The method of any one of Claims 1 to 3 wherein the maximum temperature of the enzyme solution during the heating phase is less than 950C.

5.The method of Claim 4 wherein the elevated temperature is more than 600C and less than 850C.

.

.

.

11. The method of Claim 1 wherein the heating of the lenses and solution to an elevated temperature is followed by cooling of the solution and lenses.

1. A method of cleaning and disinfecting soft contact lenses in an aqueous solution comprising a protease, the method comprising gradually heating the lenses in an aqueous solution from ambient to a temperature above 600C and below 850C for a time sufficient to clean and disinfect the lenses, said cleaning and disinfecting being conducted in the same aqueous solution.

.

.

.

1. The method of any one of Claims 12 to 14 wherein the solution is heated to a temperature of about 650C to about 750C.

1. A method of cleaning and disinfecting contact lenses in an aqueous solution comprising a microbial protease, the method comprising gradually heating the lenses in an aqueous solution from ambient to a temperature between 600C and 1000C for a time sufficient to clean and disinfect the lenses, said cleaning and disinfecting being conducted in the same aqueous solution.

.

.

.

1. The method Claim 18 (sic) or Claim 19 wherein the temperature of the aqueous solution is raised to a maximum of between 600C and 1000C.

.

.

.

24. The method of Claim 22 wherein the elevated temperature is between 650C and 750C.

Claims 27 to 32 are independent claims similar in wording to claim 1 but with different enzymes defined.

EVIDENCE

The evidence lodged in support of the opposition consists of a statutory declaration by John Michael Slattery.  This declaration includes thirteen exhibits, twelve of which are either journal articles or patent specifications.  The thirteenth exhibit and three other statutory declarations by employees of various libraries are concerned with establishing the publication dates of the various articles and specifications.

The evidence in support provides no indication of the relevance of the articles and specifications.

The applicant did not lodge any evidence in answer.

SUBMISSIONS

With respect to section 40, Mr. Slattery submitted that claim 1 is ambiguous as to what is meant by a "period of time".  According to Mr. Slattery, the claim should refer to a time for heating up and a time for temperature maintenance.  Also he said that the claim only defines a time sufficient to clean and disinfect but not to deactivate the enzyme.  Because of this the claim is not fairly based.  Mr. Slattery also submitted that the wording "deactivate....in the same aqueous solution" does not add anything to either claim 1 or claim 12.

Mr. Slattery referred to claim 2 and suggested that the "plurality of cycles" referred to in the claim lacked any support in the description and that therefore the claim lacked fair basis.

With respect to claims 3 to 5, 15 and 24, Mr. Slattery asserted that the various values referred to in these claims are not specifically mentioned in the description and therefore these claims are not fairly based.

As claim 11 refers to a cooling step Mr. Slattery suggested that claim 1 therefore does not include a cooling step and that from a practical point of view this is a requirement of the described invention.  Thus claim 1 lacks fair basis.

Mr. Slattery submitted that claim 12 is not fairly based because it does not refer to a specific time limit.  As a result, the claim does not define a method which takes a reduced amount of time compared with prior art methods.  This is equally true of claim 18.

Mr. Slattery then went on to suggest that claim 20 is redundant over claim 18 and that claims 27 to 32 all have the same defects as claim 1.

With respect to the grounds of prior publication, lack of novelty and obviousness, Mr. Slattery conceded that the document exhibited as JMS 12 would not be relied on as its publication date in Australia had not been established.

The main document relied on by the opponent to establish prior publication and lack of novelty of the opposed claims is Australian patent specification 483265 in the name of Allergan Pharmaceuticals.  It was published in Australia on 13 November 1975.

The Allergan specification discloses a method of cleaning soft contact lenses using an aqueous solution of protease.  Papain is one of the preferred enzymes.  On page 10, the specification discloses that the lenses can be cleaned in shorter time periods at elevated temperatures and exemplifies this as about 1/2 minute to 6 hours at 370C.  In one of the examples, the specification indicates that lenses were cleaned faster in an aqueous enzyme solution at an elevated temperature of 370C.  The enzyme used is trypsin.

Mr. Slattery referred to the remaining patent specifications and journal articles (except for exhibit JMS 12) which were lodged as part of the evidence in support.  While only some of these documents refer to methods of cleaning contact lenses, they are all directed to the use of enzymes.

In the light of these documents, Mr. Slattery concluded that cleaning methods using enzymes at elevated temperatures were known, and as different enzymes have different activities at different levels of temperature, it is logical to use each enzyme at its own preferred maximum operating temperature.

In respect of prior publication, Mr. Slattery referred me to a number of well known decisions which espouse tests for prior publication.  He then applied what is known as the reverse infringement test.  This test requires that for prior publication to exist, the earlier published disclosure must include all the essential integers of the claimed invention so that if the earlier disclosure had come after the claimed invention it would be an infringement of the claims.

Mr. Slattery submitted that the Allergan specification teaches a method of cleaning contact lenses using an aqueous solution of enzymes at elevated temperatures.  Mr. Slattery stated that the Allergan specification certainly does not exclude operation at temperatures in the range of 600C to 1000C.  It is quite within the purview of the teaching of this specification.

He then submitted that, as the Allergan specification discloses a cleaning time of 1 minute to 24 hours, the time limit of 60 minutes or less is also disclosed.  Mr. Slattery then suggested that if the method in the Allergan specification is operated at 600C to 1000C for 60 minutes or less then cleaning and disinfecting will occur in one step if the opposed specification is correct.

Mr. Slattery concluded this argument by submitting that if the reverse infringement test were applied the Allergan specification contains a teaching which if followed could be an infringement of the present applicant's claimed method.  Therefore the Allergan specification prior publishes the claimed method.  Mr. Slattery did not specify whether all or only some of the opposed claims are prior published.

On the other hand, Mr. Turner submitted that the Allergan specification discloses neither an elevated temperature range of 600C to 1000C nor disinfecting and cleaning in the one solution. Thus the Allergan specification does not disclose all the essential features of the presently claimed invention and therefore does not prior publish the claimed invention.

With respect to novelty, Mr. Slattery referred to relevant case law and made the point that mere workshop improvements and mechanical equivalents are types of variations which do not lead to novelty.

In the present case, Mr. Slattery submitted that the Allergan specification discloses that the advantages of using enzymes at elevated temperatures include a shorter cleaning time which is as little as one minute.  He then contended that what is suggested in the opposed specification as a substantial variation over the prior art i.e. the time reduction is non-existent.  The result of the claimed method and the method in the Allergan specification is the same.  Any difference is a mere workshop improvement or the chemical version of a mechanical equivalent.  Therefore the claimed method is not novel.

In support of this argument Mr. Slattery made reference to exhibit JMS 10 which is a copy of an article from Enzymologia Vol. XX, 1.  This article refers to papain as having an optimal temperature between 650C to 700C.  The article also indicates that papain is destroyed at 820C to 830C.  Mr. Slattery submitted that as the Allergan specification refers to papain, the claimed method is merely a workshop improvement of the method in the Allergan specification.

Mr. Turner argued that the opponent has not provided any expert evidence as to what is a workshop improvement or a mechanical equivalent.

With respect to obviousness, Mr. Slattery admitted that in the light of 3M v Beiersdorf 29 ALR 29 only the common general knowledge in the art should be considered when deciding on the question of obviousness. However Mr. Slattery put forward the view that one should not ignore the admitted prior art in the specification in suit when considering obviousness. He conceded that the specification was probably drafted in the USA but was nevertheless written for Australia and therefore does represent the prior art in Australia. Mr. Slattery pointed out that the specification discloses the fact that cleaning of contact lenses using enzymes is well known and that disinfecting the lenses at 800C for more than 10 minutes using a one hour heating cycle is also known. He submitted that these things when read in the same document lead to the conclusion that the invention is obvious.

Mr. Turner pointed out that the claimed method is a new combination of features or processes.  It is not obvious to combine these processes even though each process may be known individually.

DECISION

Section 40

I agree with Mr. Slattery that claim 1 is ambiguous with respect to what is meant by "for a period of time ....".  This could require that the solution be maintained at a temperature between 600C to 1000C for 60 minutes or less or it could mean that the solution should be heated for 60 minutes or less until it reaches a temperature of between 600C to 1000C.  This ambiguity also occurs in claims 12,18 and 27 to 32.

I also agree with Mr. Slattery's submission that claim 1 should define a heating up period and a time for temperature maintenance.  According to the second paragraph of page seven that I have referred to earlier, it is this temperature maintenance at 600C to 1000C which deactivates the enzyme and thus stops the cleaning process.  The disinfecting process also occurs during this temperature maintenance period.  I also note that the "Summary of the Invention" quite clearly specifies a temperature maintenance period of 15 minutes or less.  Also as indicated earlier, the specification states that the inventive method has the benefit of concurrent deactivation of the active enzymes by the time the cycle is complete.  Therefore I am of the opinion that claim 1 is not fairly based on the matter described in the specification because it does not define a step of maintaining the temperature of the solution at between 600C to 1000C for a period of time which is sufficient to not only deactivate the enzyme and thus stop the cleaning process but also to complete the disinfecting process.  The same defect also occurs in claims 12,18 and 27 to 32.

I also agree with Mr. Slattery that the last part of claim 1 viz. "said cleaning and disinfecting being conducted in the same aqueous solution" appears superfluous in the light of the rest of the claim.  However I do not believe that it makes the claim unclear in any way.

With respect to claim 2, I agree that it is not fairly based. There is no suggestion in the description of more than one cycle.

Claims 3,4,15 and 24 define values which are not specifically mentioned in the description but which all fall within the disclosed ranges of time and temperature.  It is difficult to see how a person skilled in the art on reading the specification would not realize that a time period of 60 minutes or less includes a time period of 50 minutes or less as defined in claim 3 for example.  Without any evidence from a person skilled in the art to the contrary, I am prepared to say that claims 3,4,15 and 24 are fairly based.

The values in claim 5 are disclosed on page seven and therefore it also is fairly based.

I do not agree with Mr. Slattery's comments in relation to claim 11 and claim 1.  While a cooling step may be a practical requirement of the described invention, I do not consider it to be essential to the described invention.  A cooling step does not contribute to the reduction in time achieved by the described invention over the prior art methods.  Therefore I do not consider that it is necessary to include a cooling step in claim 1.

Claim 12 does not define a specific time limit of 60 minutes or less but merely refers to a time sufficient to clean and disinfect the lenses.  A time of 24 hours say would be sufficient to clean and disinfect the lenses although the lenses would be cleaned and disinfected before the end of such a time period.  Clearly such a period of 24 hours is not what is intended by the described invention which is concerned with restricting the amount of time required.  I have already noted earlier in this decision that the specification indicates that the invention overcomes the disadvantages of the prior art methods of the inconvenient length of time needed to clean and disinfect the lenses by combining the two steps into a single step taking 60 minutes or less.  Therefore I agree with Mr. Slattery that the claim is not fairly based.  Claim 18 is similarly not fairly based on the matter described in the specification.

With respect to claim 20, I agree that it is redundant over claim 18.  If it is not, then claim 18 defines a method which is not fairly based on the matter described in the specification.

In summary, I have found that claims 1,2,12,18 and 27 to 32 are not fairly based, claims 1,12,18, and 27 to 32 are not clear and claim 20 is redundant.

Prior publication

With respect to prior publication I have taken heed of the test for prior publication enunciated in General Tire and Rubber Company v The Firestone Tyre and RubberCompany Ltd (1972) RPC 457 which is as follows:

"...if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated."

All of the claims in suit include a single step which requires that the lenses in the aqueous solution of proteolytic enzyme be heated to a temperature between 600C to 1000C for a period of time sufficient to clean and disinfect the lenses.  The Allergan specification does not include any suggestion of a single cleaning and disinfecting step or heating the solution to between 600C to 1000C.  It therefore cannot be said that carrying out the method of the Allergan specification will inevitably result in the claims in suit being infringed.  Therefore the Allergan specification does not prior publish any of the claims.  In this respect I agree with Mr. Turner.

While Mr. Slattery referred me to a number of documents, there is no evidence to suggest that any of these disclosures were part of the common general knowledge in the art at the time of publication of the Allergan specification.  Therefore I am not entitled to refer to any of this material in conjunction with the Allergan specification when determining whether of not the claims in suit are prior published.

In summary I find that none of the claims are prior published.

Novelty

While Mr. Slattery referred me to a number of decided cases during his submissions on lack of novelty, I will refer to two of them.

Dixon J. in Griffin v Isaacs [1942] AOJP 739 at 740 provided a test for novelty as follows:

"Where variations from a device previously published consist in matters which make no substantial contribution to the working of the thing or involve no ingenuity or inventive step and the merit if any of the two things considered as inventions is the same, it is, I think, impossible to treat the differences as giving novelty."

The Allergan specification discloses the cleaning of soft contact lenses by soaking them in an aqueous solution containing an enzyme for half a minute to 6 hours at 370C.  Presumably after this cleaning step the lenses are disinfected in a separate solution.  There is nothing in the Allergan specification to suggest that the disinfecting step is carried out using the same solution.  On page 9 of the Allergan specification there is a brief reference to a step of sterilizing and subsequent soaking of the lenses before the lenses are worn.  This step takes place after the cleaning of the lenses and in a different solution.

The difference between the method disclosed in the Allergan specification and the method claimed in the specification in suit is as I have previously mentioned in the section on prior publication.

A method which provides cleaning and disinfecting in one step seems to me to have advantages over a method which requires two steps.  Mr. Slattery has suggested that the alleged improvement of the claimed invention in the reduced period of time required to clean and disinfect the lenses is not apparent in the light of the times mentioned in the Allergan specification.  I believe that Mr. Slattery may be correct on this point.  However the specification in suit on page 2 lists other advantages which arise from the claimed method.  These include a greater convenience (one step instead of two) and a greater economy because only one lens care solution is needed instead of two.  In my opinion these are not insignificant advantages.

Thus I believe that the difference between the Allergan specification and the claims in suit makes a substantial contribution to the working of the method and the claimed method has merit over the method disclosed in the Allergan specification.

There is no evidence before me to suggest that the difference I have identified involves no ingenuity or inventiveness.  Mr. Slattery referred me to the Enzymologia article.  However there is nothing to suggest that this disclosure was part of the common general knowledge in the art in Australia before the priority date of the claims in suit.  In any case, not only is this article concerned with the effect of heat on papain in the dry state rather than in an aqueous solution but also it is concerned with the use of papain in milk clotting.  Therefore I do not consider it to be relevant to my consideration of the question of novelty.

In Nicaro Holdings v Martin Engineering 16 IPR 545 at 549, Lockhart J. refers to workshop variations and mechanical equivalents in relation to differences which do not confer novelty. While Mr. Slattery refers to workshop improvements, I am persuaded by Lockhart J. to use the term "workshop variations" rather than "workshop improvements" which Lockhart J. says is essentially a term applicable to cases of obviousness.

I do not consider that the difference between the claims in suit and the Allergan specification is a mechanical equivalent.  It seems to me that a method which consists of two steps is not an equivalent of a method which combines those two steps into one step.

Similarly I do not believe that the difference is a mechanical variation.  There is no evidence to suggest that this difference would be a variation that a skilled workman in the art would have applied to the Allergan method.

Mr. Slattery relied on the various patent specifications and journal articles to support his argument that it was well known that enzymes have different activities at different levels of temperature and that it was only logical to use each enzyme at its own preferred maximum operating temperature.  However there is no evidence to suggest that these documents represent part of the common general knowledge in the art in Australia at the relevant date.  While all these documents were published in Australia, they include US, German and Japanese patent specifications as well as overseas journal articles.  Therefore I cannot come to the conclusion that they represent the common general knowledge in Australia.

I am therefore of the opinion that the claimed method is novel in the light of the Allergan specification.

Obviousness

Mr. Slattery pointed out that the specification in suit was probably drafted in the USA but suggested that nevertheless the specification was drafted for Australia and that the admitted prior art represented part of the common general knowledge.  I do not believe that the prior art described in a specification provides proof of what was part of the common general knowledge in the art in Australia before the priority date of its claims.  Even where the specification refers to widely used methods, as is the case in the specification in suit, this does not constitute expert evidence of what was part of the common general knowledge at the time.  However even if I were prepared to accept that the prior art cleaning and disinfecting steps were part of the common general knowledge, there is no evidence before me to establish that it would be obvious for the person skilled in the art to combine the two steps into one method for the time periods and temperature ranges defined in the claims.

I am therefore of the opinion that the claimed invention is not obvious.

CONCLUSION

I have found that the opposition succeeds on the grounds that the claims in suit do not meet the requirements of section 40 but that the grounds of prior publication, novelty and obviousness have not been established.  As it is likely that the section 40 defects can be overcome, I will allow the applicant a period of 60 days from the date of this decision within which to propose amendments to overcome the defects to my satisfaction.

In accordance with the general principle that costs follow the event, I award costs against the applicant.

(R. Hallett)
Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  Spruson & Ferguson

Patent attorneys for the opponent   :  Davies Collison Cave